Insulin combination therapy in type 2 diabetes
- Conditions
- DiabetesDiabetes mellitus type 2 (DM type II)Nutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN29335793
- Lead Sponsor
- Stichting Julius Research (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. Type 2 diabetes patients, male and female, insulin naive, without good glycaemic control for at least three months despite combination of metformin and sulfonylurea therapy and who are referred for insulin therapy by their general practitioner (GP)
2. Aged 40-75 years
3. Haemoglobin HbA1c (HbA1c) >=7.5%
1. Type 1 diabetes
2. C-peptide <0.50 nmol/l
3. Liver (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 times upper limit of normal) and/or kidney (creatinine >135 in male patients, >110 in female patients) problems
4. Patients who do not read Dutch well enough to answer questionnaires
5. Pregnancy or lactation
6. Amputated leg or arm
7. Intercurrent disease at the discretion of the investigator
8. Short life expectancy
9. Contraindications or intolerancy to metformin, sulfonylurea or insulin glargine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between the two groups in the remaining insulin secretion of the beta-cells, assessed by differences in Homeostasis Model Assessment (HOMA)-beta and in fasting C-peptide.
- Secondary Outcome Measures
Name Time Method 1. Difference in mean daily dosage of insulin glargine in order to reach good glycaemic control (HbA1c <= 7.0%)<br>2. Percentage of patients with good glycaemic control after 12 months<br>3. Percentage of patients with good glycaemic control at several intervals within 12 months<br>4. Frequency of serious and of nocturnal hypoglycaemic episodes<br>5. Waist circumference<br>6. Quality of life<br>7. Patients' treatment satisfaction